Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF (RECONNECT)

Added Value of Superior Vena Cava Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation

Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear.

With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: PVI; Procedure: PVI + SVC

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Please Select
    • Brugge, Please Select, Belgium, 8000
      • Recruiting
      • AZ Sint-Jan Brugge-Oostende AV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients older than 18 years
• Patients scheduled for a repeat ablation of PAF after a previous PVI
• PV reconnection (in ≥1 PV's) found during procedure at the time of randomization

Exclusion Criteria:

• Patients with persistent AF
• Patients with durable PVI (no PVR)
• Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
• Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
• Left ventricular ejection fraction <35%.
• Cardiac surgery within the previous 90 days.
• Expecting cardiac transplantation or other cardiac surgery within 180 days.
• Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
• Documented history of a thromboembolic event within the previous 90 days.
• Diagnosed atrial myxoma.
• Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
• Women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation.
• Acute illness or active infection at time of index procedure
• Advanced renal insufficiency
• Unstable angina.
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation.
• Life expectancy less than 1 year.
• Presence of a condition that precludes vascular access.
• INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
• Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
• Unwilling or unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PVI only group; Patients allocated to this group will receive PV re-isolation alone	Procedure: PVI; PV re-isolation will be conducted according to the CLOSE-protocol. Point-by-point radiofrequency (RF) delivery will be performed aiming for a contiguous circle enclosing all PVs. RF will be delivered in a power-controlled mode (without ramping) using 35-40 Watt. The irrigation rate will be set at 30 ml/min. RF will be delivered until an ablation index (AI) of ≥400 is reached at the posterior wall and ≥550 at the anterior wall. In case of dislocation, a new RF application reaching the AI target will be applied. Maximal intertag distance between two neighboring lesions is 6 mm. In case of intra-esophageal temperature (T°) rise >38.5°C during posterior LA wall ablation, RF delivery will stopped at an AI of 300. In the absence of first pass isolation, touch-up ablation was applied until PVI. In case of reconnection during the waiting time or during the adenosine test, the site of reconnection will be located and treated with touch-up ablation until adenosine proof PVI is reached.
ACTIVE_COMPARATOR: PVI + SVC group; Patients allocated to this group will receive PV re-isolation with SVC isolation.	Procedure: PVI + SVC; Patients in this group receive PVI according to the CLOSE protocol. In addition, they will receive an SVC isolation. The circular mapping catheter will be introduced in the superior vena cava to determine baseline electrical activity and to confirm definite entrance and exit block after ablation. Ablation will be performed proximally to the SVC/right atrial junction with the contact force-catheter using circular point-by-point radiofrequency delivery with a power setting of 35W, targeting an AI ≥400. High output (25 mA) pacing will be applied before each RF application to check for phrenic nerve stimulation. In areas of phrenic nerve capture ablation will be avoided even in case of incomplete isolation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of atrial tachyarrhythmia 1 year after the index ablation	Measured on 72hr Holter monitoring	1 year after ablation
Safety measured by procedural complications	Occurence of procedural complications post procedure	From time of ablation to 1 month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time	Difference in total procedure time between groups	At time of ablation
Fluoroscopy time	Difference in fluoroscopy time between groups	At time of ablation
RF ablation time	Difference in RF ablation time between groups	At time of ablation
Atrial volume	Evaluation of the atrial volume (ml)	At time of ablation
SVC width	Evaluation of the SVC width (mm)	At time of ablation
phrenic nerve width	Evaluation of the phrenic nerve width (mm)	At time of ablation

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (ACTUAL): October 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2721

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No